STRAIGHTSHOT® 1899200 (UDI 00643169588127)Recalls & reported problems

Summary

The FDA's MAUDE database contains 373 adverse event reports that list this exact device (DI 00643169588127), received between Mar 13, 2018 and Sep 28, 2026 — classified as 2 injuries, 371 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (266 reports).

1 other recall cover devices cleared under the same FDA submission (K081277); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 373 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Overheating of Device

  It was reported that during intra op the device was getting so hot and did not feel comfortable using it. The procedure was delayed by 7 minutes in swapping handpieces. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910722 ↗
• MalfunctionSep 21, 2026Overheating of Device; Power Problem

  It was reported that intra-op, the M5 handpiece handle sometimes gets stuck and heats up after using for a minute. The speed of the handpiece was 3000 RPM with irrigation 5cc/min. The procedure was completed with a backup handpiece. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50836443 ↗
• MalfunctionSep 17, 2026Excessive Heating

  It was reported that the device was sent for preventive maintenance. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50801190 ↗
• MalfunctionSep 17, 2026Electrical /Electronic Property Problem; Overheating of Device

  It was reported that intraoperative, handpiece was running hot and cable was tangled/lumpy. Procedure was completed with backup handpiece and there was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50797770 ↗
• MalfunctionSep 8, 2026Overheating of Device; Noise, Audible

  It was reported that post-op, the M5 Handpiece was getting hot and making a buzzing noise, there was no delay in the case. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50661804 ↗
• MalfunctionAug 7, 2026Overheating of Device; Noise, Audible

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50170551 ↗
• MalfunctionJul 29, 2026Break; Overheating of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50069168 ↗
• MalfunctionJul 28, 2026Overheating of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50058442 ↗
• MalfunctionJul 14, 2026Overheating of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25809749 ↗
• MalfunctionJul 3, 2026Overheating of Device; Use of Device Problem

  IT WAS REPORTED THAT PRE-OP, THE M5 HANDPIECE WAS GETTING HOT AND WAS NOT WORKING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25702521 ↗
• MalfunctionJun 12, 2026Overheating of Device

  IT WAS REPORTED THAT THE HANDPIECE WAS OVERHEATING. THERE WAS NO PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 25481517 ↗
• MalfunctionFeb 5, 2026Overheating of Device; Power Problem

  IT WAS REPORTED THAT PREOPERATIVE, HANDPIECE WAS SET WITH 25CC/MIN IRRIGATION, 3000 RPM IN OSCILLATION MODE. HANDPIECE WAS STUCK AND OVERHEATING WITHIN A MINUTE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24265391 ↗
• MalfunctionFeb 2, 2026Overheating of Device

  IT WAS REPORTED DURING PRE-OP THAT THE DEVICE HAD OVER HEATING. IRRIGATION WAS NOT IN USE AT THE TIME OF OBSERVATION. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24234931 ↗
• MalfunctionFeb 2, 2026Overheating of Device; Power Problem

  IT WAS REPORTED THAT PRE-OP, THE M5 HANDPIECE ENGINE HEATS UP AFTER WORKING FOR SEVERAL SECONDS AND SOON IT GETS SEIZED AND STOPS WORKING. IRRIGATION WAS BEING USED, AND THE ENGINE WAS RUNNING AT 12,000 RPM. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24231484 ↗
• MalfunctionJan 28, 2026Overheating of Device

  IT WAS REPORTED THAT INTRA OP, DEVICE WAS OVERHEATING WHEN BEING USED. THERE IS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24198412 ↗
• MalfunctionJan 22, 2026Overheating of Device; Noise, Audible

  ADDITIONAL INFORMATION RECEIVED THAT THE OVERHEATING WAS OBSERVED FOR MORE THAN A MINUTE. THE DEVICE WAS RUN AT 5000RPM IN OSCILLATION MODE WITH THE DEFAULT FLOW RATE (25-30 CC/MM) OF IRRIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24157858 ↗
• MalfunctionJan 22, 2026Overheating of Device

  IT WAS REPORTED THAT PRE-OP, THE DEVICE WAS FOUND TO HAVE A HEATING ISSUE IN LESS THAN ONE MINUTE OF USING THE DEVICE. THE HANDPIECE WAS USED IN FORWARD MODE AND IRRIGATION WAS USED AT 30CC. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24149731 ↗
• MalfunctionJan 6, 2026Overheating of Device; Power Problem

  IT WAS REPORTED THAT PRE-OP, THE M5 HANDPIECE STALLED AND GOT HOT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23986637 ↗
• MalfunctionJan 5, 2026Overheating of Device; Mechanical Jam

  ADDITIONAL INFORMATION RECEIVED THAT PRE-REPAIR TEMPERATURE TEST RESULT OF HANDPIECE FOUND WITHIN TOLERANCE I.E. LESS THAN 118F.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23960314 ↗
• MalfunctionJan 5, 2026Break; Use of Device Problem; Vibration

  IT WAS REPORTED THAT PRE-OPERATION, THE M5 HANDPIECE WAS NOT WORKING AND THE TOOL WAS UNSTABLE ON HANDPIECE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23954781 ↗
• MalfunctionDec 30, 2025Break; Overheating of Device; Power Problem; Break; Overheating of Device; Power Problem

  IT WAS REPORTED THAT THE DEVICE DOES NOT FUNCTION. IT GETS HEATED UP AND STOPS RIGHT AFTER FEW SECONDS, ERROR 15 APPEARS ON THE SCREEN. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23931513 ↗
• MalfunctionDec 29, 2025Overheating of Device; Power Problem; Overheating of Device; Power Problem

  IT WAS REPORTED THAT PRE-OP, THE ROTATION STOPPED AT 7500 RPM, AND AT THE SAME TIME THE TEMPERATURE INCREASED IN LESS THAN ONE MINUTE AT 5000-6000 RPM IN OSCILLATION MODE, AND IRRIGATION WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23907699 ↗
• MalfunctionDec 25, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT PRE OP, DEVICE WAS OVER HEATING. THERE IS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23892077 ↗
• MalfunctionDec 18, 2025Overheating of Device; Overheating of Device

  ADDITIONAL INFORMATION RECEIVED, THE HANDPIECE HEATING WAS OBSERVED WHEN USED IN LESS THAN A MINUTE. IT WAS USED IN FORWARD MODE AND IRRIGATION WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23836652 ↗
• MalfunctionDec 16, 2025Overheating of Device; Power Problem; Overheating of Device; Power Problem

  IT WAS REPORTED THAT HANDPIECE WAS OVERHEATING AND ROTATIONAL PROBLEM. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23813219 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081277. One submission often covers many models, so check the product and lot details in each record.

• Z-0961-2022 · Dec 15, 2021 · Terminated
  Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFURB, Product Number EC300RF; c) MASTER CONSOLE EC300 LEGEND E